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Smith & Nephew Recalls Knees

[ Price : $8.95]

Smith & Nephew says it is recalling knees from three ranges due to a higher-than-specified iron content.

FDA Panel to Review Heartmate II PMA

[ Price : $8.95]

FDAs Circulatory System Devices Panel meets 11/30 to vote on whether to recommend approval of Thoratec Corp. HeartMate II Left Ven...

Committee to Consider Entereg NDA

[ Price : $8.95]

FDAs Gastrointestinal Drugs Advisory Committee schedules a review of Adolors NDA for Entereg for short-term treatment of post-oper...

Consensus Algorithm Seeks More Avandia Caution

[ Price : $8.95]

A diabetes management consensus statement calling for greater caution in prescribing GlaxoSmithKlines Avandia is challenged by the...

FDA Accepts Vanda NDA on Antipsychotic

[ Price : $8.95]

FDA accepts for review a Vanda Pharmaceuticals NDA for iloperidone, an investigational atypical antipsychotic indicated for treati...

FDA OKs Intervet sNADA for Horse Feed

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Federal Register Final rule: FDA approves an Intervet sNADA to revise food safety warnings on fenbendazole medicated horse feeds.

Bristol Scraps Plans on Bladder Cancer Agent

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Bristol-Myers Squibb kills a licensing deal with Pierre Fabre Medicament to seek FDA approval for vinflunine, an investigational a...

Court Nixes Provenge Case

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An Ohio federal court says it cant review FDAs May decision not to approve Dendreons Provenge because it is not a final decision....

FDA Corrects Notice on BTC Drugs

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Federal Register Notice: FDA corrects a date in a notice announcing a public meeting to obtain comments on behind-the-counter avai...

FDA Seeks Risk Analysis on Pediatric Asthma Drug Use

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FDA safety reviewers recommend a thorough risk-benefit analysis on pediatric use of GlaxoSmithKlines Serevent and Advair, and Nova...